Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric
medicine company progressing Nano-Pulse Stimulation™ (NPS™)
technology, today announced that the first CellFX® procedures in
the European Union were successfully completed. The initial
commercial use of the non-thermal, cellular-focused CellFX System
to clear common benign lesions, now expands the Company’s
controlled launch program starting with the top aesthetic
dermatologists and plastic surgeons across Europe. This strategic
rollout in Europe will run in parallel with the Company’s U.S.
controlled launch aimed at building a strong foundation of clinical
and commercial advocacy as the Company grows a promising global
business.
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As the first-of-its-kind multi-application platform powered by
NPS technology delivering nano-second pulses of electrical energy
to non-thermally clear cells while protecting adjacent non-cellular
healthy tissue, the CellFX System ushers in a new chapter in
dermatology procedures addressing everyday skin lesions.
“I am delighted to be the first aesthetic skin specialist to
perform the CellFX procedure in Europe. We see a huge number of
patients who are burdened by troublesome skin lesions, such as
sebaceous hyperplasia, seborrheic keratoses, and non-genital warts,
that can affect them at home, work and socially,” said Dr. Afschin
Fatemi, medical director of The S-thetic Group, a network of
aesthetic clinics across Germany. “With its non-thermal, cellular
mechanism, the CellFX System provides a new, consistent solution to
remove a variety of bumps and growths on the face and body that
have been historically difficult to treat. I am excited to offer
this innovative procedure in our clinics and look forward to the
enhanced results and improved patient satisfaction we can expect to
achieve.”
The prevalence of SH, SK and common, non-genital warts among
patients visiting aesthetic dermatologists today is widespread.
Based on a 2020 survey among aesthetic physicians from Germany,
Spain and France, an average of 200 patients per month who visit
aesthetic dermatology practices present with each lesion type (SH,
SK, non-genital warts). Further, patients place greater value on a
procedure to treat skin lesions over other popular aesthetic
procedures they currently receive and are willing to pay cash to
treat multiple lesions in a single visit.1
"We are at the inception of a distinctive new era as we embark
on the commercial use of the CellFX System for specific lesion
types throughout the European Union. In partnership with leading
aesthetic skin specialists across Europe, our ambition is to create
a blueprint of best practices that ensures success for the next
wave of early adopters,” said Ed Ebbers, Executive Vice President
and General Manager, Dermatology, of Pulse Biosciences. “We are
honored to work with Dr. Fatemi and we look forward to a promising
future in the European market.”
About Pulse Biosciences®
Pulse Biosciences is a novel bioelectric medicine company
committed to health innovation that has the potential to improve
the quality of life for patients. The CellFX® System is the first
commercial product to harness the distinctive advantages of the
Company’s proprietary Nano-Pulse StimulationTM (NPSTM) technology,
such as the ability to non-thermally clear cells while sparing
non-cellular tissue, to treat a variety of applications for which
an optimal solution remains unfulfilled. Nano-Pulse Stimulation
technology delivers nano-second pulses of electrical energy. The
initial commercial use of the CellFX System is to address a range
of dermatologic conditions that share high demand among patients
and practitioners for improved dermatologic outcomes. Designed as a
multi-application platform, the CellFX System offers customer value
with a utilization-based revenue model. To learn more, please visit
pulsebiosciences.com.
To stay informed about the CellFX System, please visit
CellFX.com and sign up for updates.
Pulse Biosciences, CellFX, Nano-Pulse Stimulation, NPS and the
stylized logos are among the trademarks and/or registered
trademarks of Pulse Biosciences, Inc. in the United States and
other countries.
Forward-Looking Statements
All statements in this press release that are not historical are
forward-looking statements, including, among other things,
statements relating to Pulse Biosciences’ expectations regarding
regulatory clearance and the timing of FDA, Health Canada and other
regulatory filings or approvals, and the ability of the Company to
successfully complete a 510(k) submission for the CellFX System or
for any specific indications, the ability of the Company to prepare
and provide data to FDA, Canadian and other regulatory bodies, NPS
technology including the effectiveness of such technology and the
effectiveness of related clinical studies in predicting outcomes
resulting from the use of NPS technology, the CellFX System
including the benefits of the CellFX System and commercialization
of the CellFX System, current and planned future clinical studies
and the ability of the Company to execute such studies and results
of any such studies, other matters related to its pipeline of
product candidates, the Company’s market opportunity and
commercialization plans, including the timing and results of the
controlled launch in Europe, the market for the treatment of
certain lesions, the experience of using the CellFX System, future
financial performance, and other future events. These statements
are not historical facts but rather are based on Pulse Biosciences’
current expectations, estimates, and projections regarding Pulse
Biosciences’ business, operations and other similar or related
factors. Words such as “may,” “will,” “could,” “would,” “should,”
“anticipate,” “predict,” “potential,” “continue,” “expects,”
“intends,” “plans,” “projects,” “believes,” “estimates,” and other
similar or related expressions are used to identify these
forward-looking statements, although not all forward-looking
statements contain these words. You should not place undue reliance
on forward-looking statements because they involve known and
unknown risks, uncertainties, and assumptions that are difficult or
impossible to predict and, in some cases, beyond Pulse Biosciences’
control. Actual results may differ materially from those in the
forward-looking statements as a result of a number of factors,
including those described in Pulse Biosciences’ filings with the
Securities and Exchange Commission. Pulse Biosciences undertakes no
obligation to revise or update information in this release to
reflect events or circumstances in the future, even if new
information becomes available.
1 2020 Physician (n=46) and Patient (n=190) surveys conducted in
the EU by third-party market research firm on behalf of Pulse
Biosciences, Inc.
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version on businesswire.com: https://www.businesswire.com/news/home/20210219005136/en/
Investors: Pulse Biosciences Sandra Gardiner, EVP and CFO
510.241.1077 IR@pulsebiosciences.com or Gilmartin Group Philip Trip
Taylor 415.937.5406 philip@gilmartinir.com
Media: Tosk Communications Nadine D. Tosk 504.453.8344
nadinepr@gmail.com press@pulsebiosciences.com
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